Fixation system and method

• US 6,610,079 B1
• Filed: 06/30/2000
• Issued: 08/26/2003
• Est. Priority Date: 12/14/1999
• Status: Expired due to Term

• Current Assignee: Li Medical Technologies, Inc.
• Original Assignee: Linvatec Corporation (Jefferies Financial Group, Inc.)
• Inventors: Li, Rhodemann, Li, Lehmann K.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/610,123
• Time in Patent Office: 1,152 Days
• Field of Search: 606/72, 606/75, 606/213, 606/216, 606/74, 606/153, 606/155
• US Class Current: 606/232
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 17/92 Impactors or extractors, e.g. for removing intramedullary devices insertion or extraction of artificial joints A61F2/4603
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61B 2017/922 Devices for impaction, impact element
• CPC Class Codes: A61C 8/0018 characterised by the shape
• CPC Class Codes: A61C 8/0089 Implanting tools or instruments
• CPC Class Codes: A61F 2/0805 : Implements for inserting tendons or ligaments
• CPC Class Codes: A61F 2/0811 : Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/4631 : the prosthesis being specially adapted for being cemented

Abstract

A fastener system and procedure to secure a member in a medium. The system includes a tool to deliver both the member and a flowable, curable polymer onto, into or through the medium. The flowable polymer is injected into, through or around the member. As the flowable polymer cures, it acts as either a solid filler or as an adhesive to provide fixation for the member, or to enhance fixation of the member.

Claims

1. A method for delivering a non-flowable implant and a flowable material into a medium with a delivery tool comprising:

disposing a flowable material in the delivery tool;

controlling a non-flowable implant with the delivery tool;

inserting the non-flowable implant with the delivery tool into the medium;

injecting the flowable material with the delivery tool into the medium so that the flowable material is injected through, above, below or around at least a portion of the non-flowable implant; and

allowing the flowable material to change to a non-flowable state in, on or around at least a portion of the non-flowable implant to provide fixation of the implant to the medium.

2. The method of claim 1, wherein the non-flowable implant comprises a fastener.

3. The method of claim 2, wherein the fastener has a suture attached thereto.

4. The method of claim 1, wherein the non-flowable implant comprises a suture.

5. The method of claim 1 wherein the non-flowable implant comprises tissue or bone.

6. The method of claim 1, wherein the medium comprises tissue or bone.

7. The method of claim 1, wherein the step of disposing a flowable material in the delivery tool comprises disposing an at least two component flowable curable material in the delivery tool and further comprising mixing the two components to start a curing process whereby the flowable material cures after it has been delivered into the medium to secure the non-flowable implant.

8. The method of claim 1, further comprising injecting the flowable material through a portion of the delivery tool having a hollow distal end for passage of the flowable material into the medium.

9. The method of claim 1, wherein the flowable material comprises a one component flowable curable material which is curable upon exposure to an external agent.

10. The method of claim 1, wherein the flowable material comprises at least a portion that is remodelable into tissue.

11. The method of claim 1, wherein the flowable material becomes non-flowable through a phase transition.

12. The method of claim 11, wherein the flowable material which has become non-flowable can become flowable through a reverse phase transition.

13. The method of claim 9, wherein the external agent is radiation by radiant energy.

14. The method of claim 7, wherein the at least two components comprise two liquids.

15. The method of claim 7, wherein the at least two components comprise a liquid and a powder.

16. The method of claim 1, wherein the non-flowable implant comprises a fastener having a shaft, a bore extending through the shaft, and further comprising providing a needle having a distal opening in the bore, and injecting the flowable material through the needle into the bore, the fastener having at least one opening for communication of the flowable material between the bore and the medium.

17. The method of claim 16, wherein the fastener has a plurality of openings communicating between the bore and the medium, and further comprising injecting the flowable material through ones of the plurality of openings.

18. The method of claim 17, further comprising injecting the flowable material through ones of the plurality of openings to achieve a desired distribution of the flowable material in the medium.

19. The method of claim 18, further comprising moving the needle relative to the bore of the fastener to achieve the desired distribution.

20. The method of claim 1, further comprising disposing the flowable material in at least one chamber of the delivery tool and moving a plunger in the chamber to inject the flowable material into the medium.

21. The method of claim 19, further wherein the flowable material is an at least two component material that is mixed to cause it to cure and further comprising forcing the at least two components into a mixing chamber of the delivery tool to mix the two components prior to injecting the flowable material into the medium.

22. The method of claim 1, further comprising generating a signal to indicate when the flowable material has become non-flowable to allow retraction of the delivery tool.

23. The method of claim 1, further where the medium comprises first and second members and further wherein the non-flowable implant comprises a staple device for attaching the first member to the second member and further comprising injecting the flowable material into two legs of the staple device to secure each of the two legs in the medium, with the two legs penetrating through the first member into the second member to secure the first member to the second member.

24. The method of claim 1, further comprising providing a penetrating distal end on the non-flowable implant and forcing said non-flowable implant into the medium with the delivery tool.

25. The method of claim 1, further comprising using a distal end of the delivery tool to penetrate into the medium.

26. The method of claim 1, further comprising drilling a hole in the medium and inserting the non-flowable implant in the hole.

27. The method of claim 26, further comprising drilling two holes in the medium and wherein the non-flowable implant comprises a staple device having two legs, and inserting the two legs in the respective holes.

28. The method of claim 27, wherein the step of drilling comprises drilling two non-parallel holes in the medium.

29. The method of claim 28, wherein the step of drilling two non-parallel holes comprises drilling the holes so that distal ends thereof interconnect and the step of injecting the flowable material comprises injecting the flowable material so that the flowable material in each hole contacts the flowable material in the other hole.

30. The method of claim 1, wherein a distal end of the delivery tool comprises a surgical needle having an internal bore for the flowable material, and further comprising attaching a suture to a distal portion of the needle, and injecting the flowable material through the needle around the suture in the medium, and withdrawing the needle, leaving the suture secured by the flowable material that has become non-flowable in the medium.

31. The method of claim 30, further comprising providing said internal bore of the needle for the flowable material having an increased diameter portion at the distal end thereof, whereby a knot of the suture can be disposed in the increased diameter portion.

32. The method of claim 31, further comprising providing a longitudinally extending slot in the needle communicating with the needle bore at the distal end, thereby to allow the needle to be removed from the suture before or after when the flowable material has become non-flowable around the suture.

33. The method of claim 30, further comprising providing two needles on the delivery tool, with a suture attached between the two needles for use as a suture staple in the medium.

34. The method of claim 1, further comprising providing at least one sleeve attached to a flexible member, using the delivery tool to insert the sleeve in the medium, and injecting the flowable material into the sleeve using the delivery tool, the sleeve having at least one opening communicating with the medium, the step of injecting including forcing the flowable material through the at least one opening into the medium and allowing the flowable material to become non-flowable to secure the sleeve in the medium.

35. The method of claim 34, further comprising providing a sleeve on two ends of a length of the flexible member, inserting the sleeve on each end into the medium with the delivery tool and injecting the flowable material with the delivery tool into the two sleeves to secure the sleeves to the medium.

36. The method of claim 30, wherein any component of the non-flowable implant and flowable material is at least one of biodegradable, bioabsorbable, remodelable, and permanent.

37. The method of claim 34, wherein the medium comprises first and second members, further comprising disposing the sleeve through the first member, through the flexible member and then into the second member to form a loop around a portion of the first member thereby to secure the first member to the second member.

38. The method of claim 1, wherein the delivery tool comprises a rotatable instrument, and further comprising providing the non-flowable implant with a screw thread to enable threading of the non-flowable implant into the medium by rotating the delivery tool.

39. The method of claim 1, wherein the delivery tool comprises a device for applying an axial force to the non-flowable implant to cause the non-flowable implant to be inserted into the medium.

40. The method of claim 39, wherein the non-flowable implant is driven into the medium by the delivery tool without predrilling a hole.

41. The method of claim 39, further comprising predrilling a hole in the medium for the non-flowable implant.

42. A tool for delivering a non-flowable implant and a flowable material into a medium comprising:

a chamber for the flowable material;

a longitudinally extending member having a bore;

a holder for the non-flowable implant disposed at a distal portion of the longitudinally extending member;

the bore being provided for delivering the flowable material into the medium so that the flowable material is injected through, above, below or around at least a portion of the non-flowable implant; and

wherein

the flowable material changes to a non-flowable state in, on or around at least a portion of the non-flowable implant to provide fixation of the implant to the medium.

43. The tool of claim 42, wherein the non-flowable implant comprises a fastener.

44. The tool of claim 43, wherein the fastener has a suture attached thereto.

45. The tool of claim 42, wherein the non-flowable implant comprises a suture.

46. The tool of claim 42, wherein the non-flowable implant comprises tissue or bone.

47. The tool of claim 42, wherein the medium comprises tissue or bone.

48. The tool of claim 42, wherein the flowable material comprises an at least two component flowable curable material and further comprising a mixing chamber for mixing the two components to start a curing process whereby the flowable material cures after it has been delivered into the medium to secure the non-flowable implant in the medium.

49. The tool of claim 42, further wherein the delivery tool has a hollow distal end for passage of the flowable material into the medium.

50. The tool of claim 42, wherein the flowable material comprises a one component flowable curable material which is curable upon exposure to an external agent.

51. The tool of claim 42, wherein the flowable material comprises at least a portion that is remodelable into tissue.

52. The tool of claim 42, wherein the flowable material becomes non-flowable through a phase transition.

53. The method of claim 52, wherein the flowable material which has become non-flowable can become flowable through a reverse phase transition.

54. The tool of claim 50, wherein the external agent is radiant energy.

55. The tool of claim 48, wherein the at least two components comprise two liquids.

56. The tool of claim 48, wherein the at least two components comprises a liquid and a powder.

57. The tool of claim 42, wherein the non-flowable implant comprises a fastener having a shaft, a bore extending through the shaft, and further wherein the longitudinally extending member comprises a needle received in the bore of the shaft and having an internal bore, the needle bore having a distal opening, whereby the flowable material is injected through the needle into the bore of the fastener, the fastener having at least one opening for communication of the flowable material between the bore of the shaft and the medium.

58. The tool of claim 57, wherein the fastener has a plurality of openings communicating between the shaft bore and the medium, and further wherein the flowable material is injected through ones of the plurality of openings.

59. The tool of claim 58, further wherein the flowable material is injected through ones of the plurality of openings to achieve a desired distribution of the flowable material in the medium.

60. The tool of claim 59, further wherein the needle is movable relative to the bore of the fastener to achieve the desired distribution.

61. The tool of claim 42, further comprising at least one chamber for the flowable material and a plunger in the chamber to inject the flowable material into the medium.

62. The tool of claim 61, further wherein the flowable material is an at least two component material that is mixed to cause it to cure and further comprising a mixing chamber to mix the two components prior to injecting the flowable material into the medium.

63. The tool of claim 42, further comprising a signal generator to indicate when the flowable material has become non-flowable to allow retraction of the delivery tool from the medium.

64. The tool of claim 42, further where the medium comprises first and second members and further wherein the non-flowable implant comprises a staple device for attaching the first member to the second member and further wherein the staple device has two legs for insertion into the medium, with the two legs penetrating through the first member into the second member to secure the first member to the second member.

65. The tool of claim 42, further comprising a penetrating distal end on the non-flowable implant whereby the implant can be forced into the medium with the delivery tool.

66. The tool of claim 42, further comprising a distal end of the delivery tool for penetrating into the medium.

67. The tool of claim 42, further comprising means for drilling a hole in the medium prior to insertion of the non-flowable implant in the hole.

68. The tool of claim 67, further comprising a guide for drilling two holes in the medium and wherein the non-flowable implant comprises a staple device having two legs for insertion in the respective holes.

69. The tool of claim 68, wherein the guide comprises a drill guide for drilling two non-parallel holes in the medium.

70. The tool of claim 69, wherein the guide for drilling two non-parallel holes comprises a guide arranged for drilling the holes so that distal ends thereof interconnect whereby the flowable material injected in each hole contacts the flowable material in the other hole.

71. The tool of claim 42, further comprising a suture attached to the distal end of the needle, whereby the flowable material can be injected through the needle around the suture in the medium, the needle being withdrawn, leaving the suture secured by the flowable material that has become non-flowable in the medium.

72. The tool of claim 71, further wherein said needle has an internal bore for the flowable material having an increased diameter portion at the distal end thereof, whereby a knot of the suture can be disposed in the increased diameter portion.

73. The tool of claim 72, further comprising a longitudinally extending slot in the needle communicating with the needle bore at the distal end, thereby to allow the needle to be removed from the suture when the flowable material has become non-flowable around the suture.

74. The tool of claim 71, further comprising two needles on the delivery tool, with a suture attached between the two needles for use as a suture staple in the medium.

75. The tool of claim 42, further comprising at least one sleeve attached to a flexible member, the sleeve being insertable into the medium, the sleeve having at least one opening communicating with the medium, whereby the flowable material is injectable through the at least one opening into the medium to thereby secure the sleeve in the medium once the flowable material has become non-flowable.

76. The tool of claim 75, further comprising a sleeve on each of two ends of a length of the flexible member for insertion into the medium whereby the flowable material can be injected into the two sleeves to secure the sleeves to the medium as a staple.

77. The tool of claim 75, wherein any component of the non-flowable implant and flowable material is at least one of biodegradable, bioabsorbable, remodelable and permanent.

78. The tool of claim 75, wherein the medium comprises a first member and a second member, further comprising means for disposing the sleeve through the first member, through the flexible member and then into the second member to form a loop around a portion of the first member thereby to secure the first member to the second member.

79. The tool of claim 42, wherein the delivery tool comprises a rotatable instrument, and further wherein the non-flowable implant has a screw thread to enable threading of the non-flowable implant into the medium by rotating the delivery tool.

80. The tool of claim 42, wherein the delivery tool comprises a device for applying an axial force to the non-flowable implant to cause the non-flowable implant to be inserted into the medium.

81. The tool of claim 80, wherein the non-flowable implant is driven into the medium by the delivery tool without predrilling a hole.

82. The tool of claim 80, further comprising means for predrilling a hole in the medium for the non-flowable implant.

83. The tool of claim 42, further comprising a proximal handle that functions to allow insertion of the implant and injection of the flowable material into the medium.

84. The tool of claim 83, wherein the handle includes a trigger for actuating movement of the flowable material from the chamber into the medium for securing the implant in the medium.

85. A tool for installing a non-flowable implant and a flowable material for securing the implant in a medium, the tool comprising:

a hollow distal longitudinal section having at least a portion in contact with at least a portion of the implant;

the distal longitudinal section of the tool being capable of controlling the implant and delivering the flowable material into the medium; and

the distal longitudinal section being connected to a proximal handle that functions to allow insertion of the implant and injection of the flowable material into the medium.

86. A method for installing a non-flowable implant and a flowable material for securing the implant in a medium, the method comprising:

using an installation tool having a hollow distal longitudinal section with at least a portion in contact with at least a portion of the implant;

controlling the implant and delivering the flowable material into the medium with the distal longitudinal section; and

manipulating a proximal handle of the tool to both insert the implant and inject the flowable material into the medium thereby securing the implant in the medium.

87. A surgical implant comprising:

a length of a flexible material;

at least one sleeve having at least one axial hole therethrough and at least one transverse opening communicating with the axial hole;

one end of the flexible material being connected to the sleeve;

the sleeve being adapted to be received in a medium for securement in the medium, the sleeve being adapted to receive a flowable curable material that is injected through the axial hole and through the transverse opening to contact the medium thereby to secure the sleeve in the medium.

88. The implant of claim 87, further comprising a plurality of transverse openings communicating with the axial hole.

89. The implant of claim 87, wherein the flexible material comprises suture.

90. The implant of claim 87, wherein the axial hole is adapted to receive a device for injecting the flowable curable material.

91. The implant of claim 87, further comprising a second sleeve attached to a second end of the flexible material, whereby the implant functions as a surgical staple.

92. The implant of claim 87, wherein any component of the implant is at least one of biodegradable, bioabsorbable, remodelable and permanent.

93. The implant of claim 87, further comprising a penetrating end at a distal portion of the sleeve for penetration into the medium.

94. The implant of claim 90, wherein the injecting device comprises a needle having an internal bore and an opening at a distal end thereof for injecting the flowable curable material.

95. The implant of claim 94, wherein the needle is received in the axial hole and is movable in the axial hole to effect a desired distribution of the flowable material in the medium.

96. A surgical implant comprising:

a fastener having a shank, the shank having an axial opening therein and at least one transverse opening communicating with the axial opening and an exterior of the shank; and

a flowable curable material received in the axial opening and through the transverse opening for contacting at least a portion of the exterior of the shank for securing the fastener to a medium in which the fastener is inserted;

further comprising a suture attached to the fastener.

97. The implant of claim 96, wherein the shank has a plurality of transverse openings.

98. The implant of claim 97 wherein the axial opening is adapted to receive a needle of a tool for injecting the flowable curable material into the implant through the axial hole.

99. The implant of claim 98, wherein the needle is movable in the axial hole for effecting a desired distribution of the flowable curable material in the medium.

100. The implant of claim 96, further wherein the implant is adapted to receive radiant energy for curing the flowable curable material.

101. The implant of claim 96, wherein the shank has an external screw thread.

102. The implant of claim 96 further comprising a head at one end of the shank.

103. A surgical staple device for stapling into a medium, the staple device comprising:

two sleeves;

a bridge extending between the sleeves whereby the sleeves can be disposed substantially perpendicularly to the bridge;

the sleeves having an axial hole therethrough for a flowable curable material, the sleeves each having at least one transverse opening extending between the axial hole and an external surface of the sleeve for communicating the flowable curable material between the axial hole and the medium for scuring the sleeve to the medium.

104. The surgical staple of claim 103 wherein the bridge is flexible.

105. The surgical staple of claim 104, wherein the bridge comprises a suture.

106. The surgical staple of claim 103, further comprising a flowable curable material contacting at least a portion of the sleeve to secure the staple in the medium.

107. The surgical staple of claim 103, further comprising a plurality of transverse openings in the sleeve.

108. The surgical staple of claim 103, further comprising a penetrating point at a distal end of each sleeve.

109. The surgical staple of claim 103, wherein the axial hole is adapted to receive a device for distributing the flowable curable material to the medium.

110. A surgical implant comprising:

a length of suture having ends for disposition in two respective holes in a medium to secure a first tissue to the medium, the two ends being disposed through respective holes in the first tissue and into respective aligned holes in the medium; and

a flowable curable material disposed about at least a portion of each of the ends in the holes in the medium, the flowable curable material being adapted to secure the ends to the medium.